The Effects Of I-PRF On Gingivectomy and Gingivoplasty

Not Applicable

Completed

• Conditions: Wound Heal
• Interventions: Procedure: Gingivectomy anad gingivoplasty; Other: İnjectable platelet rich fibrin

• Registration Number: NCT05871190
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

The study aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF) applications on early wound healing after gingivectomy and gingivoplasty surgery. In this randomized controlled single-blind study, gingivectomy and gingivoplasty surgeries were performed on 46 patients. The postoperative I-PRF-applied surgery areas were compared with control regions. The surgical areas were stained with Mira-2 tone and evaluated in the ImageJ program. Wound healing was evaluated by using the Modified Manchester Scar (MMS) scale and Landry, Turnbull, and Howley (LTH) index. Vascular endothelial growth factor (VEGF) and fibroblast growth factor 10 (FGF-10) concentrations were assessed by enzyme-linked immunoabsorbent assay (ELISA). The seven-day Visual Analog Scale was used to assess pain level.

Considering the results found, I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-23
• Primary Completion: 2022-03-15
• Study Completion: 2022-05-20
• Status Verified: 2023-05
• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Last Update Submitted: 2023-05-15
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

(a) systemically healthy patients ages 15-40 years, (b) pregnancy or lactation, (c) patients with chronic inflammatory gingival overgrowth in the mandibular and maxillary anterior area, (d) no attachment and bone loss, (e) not using immunosuppressive agents, systemic corticosteroids, chemotherapy, and/or radiotherapy drugs taken or prescribed 2 months before the study attempt, which may affect the study results, wound healing, and coagulation mechanism, and (f) patients with sufficient oral hygiene.

Exclusion Criteria

(a) patients who had a history of periodontal treatment in the last 6 months, (b) smokers and alcohol users, those who used drugs that may cause gingival enlargement in the last 6 months, (c) patients with poor communication, and (d) patients who did not attend controls at designated times.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Gingivectomy anad gingivoplasty	closure of the wound site with only a periodontal dressing after a gingivectomy with the conventional method.
Test group	İnjectable platelet rich fibrin	I-PRF is placed on the wound site after a gingivectomy with the conventional method and closed with a periodontal dressing
Test group	Gingivectomy anad gingivoplasty	I-PRF is placed on the wound site after a gingivectomy with the conventional method and closed with a periodontal dressing

Primary Outcome Measures

Name	Time	Method
effects of I-PRF on wound healing and epithelialization	seven months	I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations.

Secondary Outcome Measures

Name	Time	Method
effects of biochemical markers on wound healing	seven months	In order to see the effects of biochemical markers on wound healing, gingival crevicular fluid samples should be taken at more frequent intervals.

Trial Locations

Locations (1)

University of Health Sciences; Ankara, Turkey; 🇹🇷 Ankara, Turkey